510(k) Report

510(k) · Cleared

Cleared

Medical Support Stockings

K951234510(k) TraditionalCleared May 18, 199559-day reviewClass II21 CFR 880.5780

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Jobst A Beiersdorf Co. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Cleared on May 18, 1995 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 18, 1995
Review
59 days
Class
Class II
Product code
DWL
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951234 Medical Support StockingsJobst A Beiersdorf Co. · 1995
  2. Descendant · cites it directly · 0 of its ownK040084 Lifestyle Circulatory EnhancerAdvanced Circulatory Systems, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K040084Lifestyle Circulatory EnhancerAdvanced Circulatory Systems, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951234Medical Support StockingsJobst A Beiersdorf Co.1995—
+1K040084Lifestyle Circulatory EnhancerAdvanced Circulatory Systems, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K951234, 1995–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DWL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040084Lifestyle Circulatory EnhancerAdvanced Circulatory Systems, Inc.20040

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K040084 (Advanced Circulatory Systems, Inc., 2004) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DWL devices

DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWL

1in 2014

2007: 12009: 22010: 32011: 22012: 52013: 32014: 1
2007high 5 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWL

111in 2013

2010: 214 days median2012: 43 days median2013: 111 days median
2007high 214 (2010) · low 43 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DWL

No recall names DWL since 2007.

Adverse event reports per year · DWL

2in 2025

2007: 12009: 32010: 72011: 42012: 102013: 42014: 22015: 12017: 42018: 22019: 12020: 32021: 22022: 12023: 22025: 2
2007high 10 (2012) · low 0 (2008)2025

MAUDE reports naming product code DWL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20080—00
20092—03
2010321407
20112—04
2012543010
2013311104
20141—02
20150—01
20160—00
20170—04
20180—02
20190—01
20200—03
20210—02
20220—01
20230—02
20240—00
20250—02
20260—0—
Cite this page

510(k) Report. “K951234: Medical Support Stockings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951234

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026